Depression Treatment and Risk for Cardiovascular Disease | NCT06170255

Studies
Depression Treatment and Risk for Cardiovascular Disease

NCT06170255

Sponsor

East Carolina University

Status

Completed

Last Update Posted

Dec 14, 2023Actual

Enrollment

16Actual

Phase

Phase 1Phase 2

Conditions

Depression

Interventions

Behavioral Activation (BA)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2014Actual

Primary Completion Date

Oct 2, 2017Actual

Completion Date

Oct 2, 2017Actual

First Submitted Date

Nov 17, 2023

First Submission Date that Met QC Criteria

Dec 6, 2023

First Posted Date

Dec 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2023

Last Update Posted Date

Dec 14, 2023Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was designed to determine the feasibility of a Randomized Controlled Trial (RCT) that involved treating depression among participants with an elevated risk for cardiovascular disease. It is expected that treating depression through non-pharmacological means will impact heart rate variability, a proximal measure of CVD risk.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Depression treatment	Experimental	Participants receive behavioral therapy for depression	Behavioral: Behavioral Activation (BA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Behavioral Activation (BA)	Behavioral	Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility	Feasibility of the study including recruitment, enrollment, and retention rates	2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)

Secondary Outcomes

Measure	Description	Time Frame
Heart Rate Variability (HRV)	Change in HRV from enrollment to post-treatment	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females age 21-75

Meet diagnostic criteria for major depressive disorder

Framingham risk score indicating a greater than negligible 10-year risk (3% or greater) for cardiovascular disease.

Levels of depressive symptoms of at least moderate level (beck depression inventory II score > 19 of 63 possible points; or a Hamilton depression rating scale > 12 of 50 possible points)

Exclusion Criteria:

A verbal expression of current, significant, suicidal ideation; a score of > 15 on the beck scale for suicidal ideation

Score of >1 on any single item of the Beck Scale for Suicidal Ideation

Score of > 1 on the item assessing suicidal ideation on the beck depression inventory II.

Psychiatric diagnoses that could potentially interfere with depression treatment (current post traumatic stress disorder, bipolar I disorder, obsessive-compulsive disorder, bulimia or anorexia nervosa, schizophrenia, and panic disorder)

Current use of an antidepressant medication

Currently in psychotherapy.

Current use of a beta blocker, anxiolytic (benzodiazepine), antipsychotic agent

Diagnosis of CVD.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior